ID

30135

Description

Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Keywords

Versions (2)
  1. 5/13/18 5/13/18 -
  2. 5/14/18 5/14/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 14, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Oral GW786034 treatment for ovarian cancer NCT00281632

English

Visit description: Treatment Period 1. Day 8

1 forms  
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Vital signs
Description

Vital signs

Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood pressure, systolic
Description

Blood pressure, systolic

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood pressure, diastolic
Description

Blood pressure, diastolic

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Temperature
Description

Temperature

Data type

float

Measurement units
  • ° C
Alias
UMLS CUI [1]
C0039476
° C
Local Laboratory - Haematology
Description

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C0022885
Lab ID
Description

Lab ID

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Laboratory name
Description

Laboratory name

Data type

text

Alias
UMLS CUI [1]
C1882331
Address
Description

Laboratory Address

Data type

text

Alias
UMLS CUI [1]
C3262820
Date Sample taken Haematology
Description

Date Sample taken Haematology

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1302413
Haematocrit (HCT)
Description

Haematocrit (HCT)

Data type

float

Alias
UMLS CUI [1]
C0018935
Haemoglobin (Hb)
Description

Haemoglobin (Hb)

Data type

float

Alias
UMLS CUI [1]
C0518015
Platelet count (absolute)
Description

Platelet count (absolute)

Data type

float

Alias
UMLS CUI [1]
C0032181
White blood cell count (WBC) (Absolute)
Description

White blood cell count (WBC) (Absolute)

Data type

float

Alias
UMLS CUI [1]
C0023508
Neutrophil count (absolute)
Description

Neutrophil count (absolute)

Data type

float

Alias
UMLS CUI [1]
C0948762
Lymphocyte count (absolute)
Description

Lymphocyte count (absolute)

Data type

float

Alias
UMLS CUI [1]
C3544087
Local Laboratory - Clinical Chemistry
Description

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0022885
Lab ID
Description

Lab ID

Data type

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0600091
Laboratory name
Description

Laboratory name

Data type

text

Alias
UMLS CUI [1]
C1882331
Address
Description

Laboratory Address

Data type

text

Alias
UMLS CUI [1]
C3262820
Date sample taken clinical chemistry
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1302413
Alkaline phosphatase
Description

Alkaline phosphatase

Data type

float

Alias
UMLS CUI [1]
C0201850
ALT (SGPT)
Description

ALT (SGPT)

Data type

float

Alias
UMLS CUI [1]
C0201836
AST (SGOT)
Description

AST (SGOT)

Data type

float

Alias
UMLS CUI [1]
C0201899
Albumin
Description

Albumin

Data type

float

Alias
UMLS CUI [1]
C0201838
Total bilirubin
Description

Total bilirubin

Data type

float

Alias
UMLS CUI [1]
C0201913
Blood Urea Nitrogen
Description

BUN

Data type

float

Alias
UMLS CUI [1]
C0005845
Calcium
Description

Calcium

Data type

float

Alias
UMLS CUI [1]
C0201925
Serum Creatinine
Description

Serum Creatinine

Data type

float

Alias
UMLS CUI [1]
C0201976
Glucose (fasting)
Description

Glucose (fasting)

Data type

float

Alias
UMLS CUI [1]
C0583513
LDH
Description

LDH

Data type

float

Alias
UMLS CUI [1]
C0202113
Potassium
Description

Potassium

Data type

float

Alias
UMLS CUI [1]
C0202194
Sodium
Description

Sodium

Data type

float

Alias
UMLS CUI [1]
C0337443
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product
Description

investigational product

Data type

text

Alias
UMLS CUI [1]
C0304229
Start Date
Description

investigational product start date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Stop Date
Description

investigational product stop date

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Dose
Description

investigational product dosage

Data type

integer

Measurement units
  • mg/day
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0304229
mg/day
If there were any dosing deviations / changes, give reason
Description

reason for dosing deviations changes

Data type

text

Alias
UMLS CUI [1,1]
C1515926
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0392360
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Similar models

Visit description: Treatment Period 1. Day 8

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Vital signs
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Blood pressure, systolic
Item
Blood pressure, systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure, diastolic
Item
Blood pressure, diastolic
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Laboratory Address
Item
Address
text
C3262820 (UMLS CUI [1])
Date Sample taken Haematology
Item
Date Sample taken Haematology
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Haematocrit (HCT)
Item
Haematocrit (HCT)
float
C0018935 (UMLS CUI [1])
Haemoglobin (Hb)
Item
Haemoglobin (Hb)
float
C0518015 (UMLS CUI [1])
Platelet count (absolute)
Item
Platelet count (absolute)
float
C0032181 (UMLS CUI [1])
White blood cell count (WBC) (Absolute)
Item
White blood cell count (WBC) (Absolute)
float
C0023508 (UMLS CUI [1])
Neutrophil count (absolute)
Item
Neutrophil count (absolute)
float
C0948762 (UMLS CUI [1])
Lymphocyte count (absolute)
Item
Lymphocyte count (absolute)
float
C3544087 (UMLS CUI [1])
Item Group
Local Laboratory - Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Laboratory Address
Item
Address
text
C3262820 (UMLS CUI [1])
Date sample taken
Item
Date sample taken clinical chemistry
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
BUN
Item
Blood Urea Nitrogen
float
C0005845 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
Glucose (fasting)
Item
Glucose (fasting)
float
C0583513 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
investigational product
Code List
Investigational Product
CL Item
GW786034 (1)
investigational product start date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
investigational product stop date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
investigational product dosage
Item
Dose
integer
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
If there were any dosing deviations / changes, give reason
text
C1515926 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for dosing deviations changes
Code List
If there were any dosing deviations / changes, give reason
CL Item
Hypertension (17)
CL Item
Proteinuria (18)
CL Item
Fatigue (19)
CL Item
Diarrhea (20)
CL Item
Mucositis (21)
CL Item
Other Toxicity (22)
CL Item
Recovered from Toxicity (23)
CL Item
lntercurrent Illness (24)
CL Item
Subject Non-compliance (25)
CL Item
Investigator Error (26)
CL Item
Other, specify (CT)
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